Clinical Trial Quality Assurance Project Manager - Poland
Translational Research in Oncology
Warsaw, PL
4 d. temu

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a Clinical Quality Assurance Project Manager to join our Quality Assurance & Regulatory Affairs team. Reporting to the Clinical Quality Assurance Unit Manager, this position will be either home based/remote or hybrid depending on your location. This position will require international travel on an as needed basis.

If you are a Clinical Trial Quality Assurance Professional who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you!

Responsibilities:

  • Along with the Clinical QA Unit Manager and the Department Head, this position will be responsible for developing and maintaining the Quality Management System of the Organization, including:
    • Creation and revision of written procedures,
    • Conducts trending and metrics analysis for the QA activities,
    • Development of training materials on company procedures, ICH-GCP and applicable regulatory requirements,
    • Training of employees on applicable regulatory requirements.
  • This position will be involved in trial specific activities including, although not limited to:
    • development of trial specific audit plans
    • review of trial specific documents
    • provide QA support to operational teams
    • Good Clinical Practice (GCP) advice as requested
    • support any Sponsor site audit
  • Responsible to conduct and/or support on-site or remote internal and external audits (internal process audits, investigators site audits, vendor audits, document audits).
  • Assist in hosting Sponsor audits and inspections.

Qualifications:

  • Minimum of a Bachelor’s Degree in a scientific/medical discipline: BSc or equivalent
  • At least 2 years of experience in Quality Assurance in clinical research (i.e. pharmaceutical industry or CRO)
  • Additional education and/or training in Clinical Quality Assurance will be considered an asset.
  • Significant practical experience in performing investigator site audits is compulsory
  • Advanced knowledge of ICH-GCP guideline FDA and/or EU regulations is required
  • Knowledge of global regulatory framework for clinical trials and Computerized System Validation (CSV) principles is an asset
  • Knowledge in oncology is preferred,
  • Fluent oral and written English is required,
  • Good communication skills (e.g. training, presentation) are essential,
  • Computer skills, such as proficiency in Word, Excel, Power Point, are required,
  • Ability to travel worldwide (mainly in Europe and occasionally in RoW), on an as needed basis (approximately 15 to 20% of working time)

What TRIO Can Offer You:

  • Flexible working hours
  • Work from Home
  • Home Office Allowance

All interviews are currently being conducted virtually - via phone or video. We thank all candidates for their interest; only those selected for an interview will be contacted.

Integrity • Teamwork • Passion

Powered by JazzHR

Zgłoś tę pracę
checkmark

Thank you for reporting this job!

Your feedback will help us improve the quality of our services.

Aplikuj
Mój adres email
Klikając przycisk "Kontynuuj", wyrażam zgodę neuvoo na przetwarzanie moich danych i wysyłanie powiadomień e-mailem, zgodnie z zasadami przedstawionymi przez neuvoo. W każdej chwili mogę wycofać moją zgodę lub zrezygnować z subskrypcji.
Kontynuuj
Formularz wniosku